vaccine therapy and interleukin-12 with either alum or sargramostim after surgery in treating patients with melanoma

Conditions: Intraocular Melanoma; Melanoma (Skin)

Summary: rationale: vaccines made from peptides may make the body build an immune response. combining vaccine therapy with interleukin-12 and either alum or sargramostim may kill more tumor cells. purpose: randomized phase ii trial to compare the effectiveness of combining vaccine therapy with interleukin-12 and either alum or sargramostim in treating patients who have undergone surgery for stage ii, stage iii, or stage iv melanoma.

objectives: * compare the immune reactivity in patients with resected stage iib, iic, iii, or iv melanoma vaccinated with tyrosinase, gp100, and mart-1 peptides emulsified with montanide isa-51 with interleukin-12 and either alum adjuvant or sargramostim (gm-csf). outline: this is a randomized study. patients are stratified according to disease stage (cutaneous stage iib, iic, iii, and iv vs ocular and mucosal stage iii and iv). patients are randomized to 1 of 3 treatment arms. * arm i: patients receive vaccine with tyrosinase:368-376 (370d)/gp100:209-217 (210m)/mart-1:26-27 (27l) peptides emulsified with montanide isa-51 (isa-51), low-dose interleukin-12 (il-12) subcutaneously (sc), and alum adjuvant sc on day 1 of weeks 1, 3, 5, 7, 11, 15, 19, 27, and 53. * arm ii: patients receive peptide vaccine emulsified with isa-51, high-dose il-12 sc, and alum adjuvant sc on day 1 of weeks 1, 3, 5, 7, 11, 15, 19, 27, and 53. * arm iii: patients receive peptide vaccine emulsified with isa-51 on day 1 and low-dose il-12 sc and sargramostim (gm-csf) sc on days 1-5 of weeks 1, 3, 5, 7, 11, 15, 19, 27, and 53. patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. projected accrual: a total of 60 patients (20 per treatment arm) will be accrued for this study within 3 years.

Eligibility criteria:
disease characteristics: * diagnosis of stage iib, iic, iii, or iv cutaneous melanoma or stage iii or iv ocular or mucosal melanoma * resected or rendered disease-free * hla-a2.1-positive by standard cytotoxicity assay * tumor tissue must be available for analysis of gp100 staining and tyrosinase and mart-1 expression by immunohistochemistry * must be positive for at least 1 antigen * failed, ineligible for, or refused prior interferon alfa patient characteristics: age: * 18 and over performance status: * ecog 0-1 life expectancy: * not specified hematopoietic: * wbc at least 3,000/mm\^3 * granulocyte count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 * hemoglobin at least 9.0 g/dl * no bleeding disorder hepatic: * bilirubin no greater than 2.0 mg/dl * sgot/sgpt no greater than 2.5 times normal * no coagulation disorder * hepatitis surface antigen b negative * hepatitis c negative renal: * creatinine no greater than 2.0 mg/dl cardiovascular: * no major cardiovascular illness pulmonary: * no major respiratory illness immunologic: * no prior uveitis * no prior autoimmune inflammatory eye disease * no immune hemolytic anemia * no other active autoimmune disease other: * hiv negative * no major gastrointestinal illness * no other malignancy within the past 5 years except squamous cell skin cancer or carcinoma in situ of the cervix curatively treated at least 30 days ago * no major systemic infection (e.g., pneumonia or sepsis) * no other major medical illness * no prior allergic reaction to montanide isa-51 or alum adjuvant * no requirement for steroid therapy * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * see disease characteristics * no prior tyrosinase:368-376 (370d), gp100:209-217 (210m), or mart-1:26-35 (27l) peptides chemotherapy: * at least 1 month since prior adjuvant chemotherapy for this disease * no concurrent adjuvant chemotherapy endocrine therapy: * no concurrent steroids radiotherapy: * at least 1 month since prior radiotherapy for this disease * no concurrent radiotherapy surgery: * see disease characteristics other: * at least 1 month since other prior therapy, including adjuvant therapy, for this disease * no other concurrent therapy, including adjuvant therapy

Keywords: iris melanoma ciliary body and choroid melanoma, small size ciliary body and choroid melanoma, medium/large size extraocular extension melanoma recurrent intraocular melanoma stage ii melanoma stage iii melanoma stage iv melanoma recurrent melanoma